跳至主要内容
临床试验/NCT02838563
NCT02838563终止不适用

Validation of a Scale of Well-Being Assessment (SIWA) in Patients With Alzheimer's Disease or a Related Disease.

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2016年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
135
试验地点
1
主要终点
Correlation between SIWA and an other quality of life scale (Qol-AD)

研究概览

简要总结

Current scales are not suited to a direct measure for the elderly with cognitive disorders and are difficult to handle for the care teams. In this context, a visual analog scale was created to answer a single question "How are you feeling now, immediately?" with the help of pictograms. This study aims to assess the validity and reliability of the Scale of Well-Being Assessment (SIWA) (in french : Echelle d'Evaluation Instantanée du Bien-Etre (EVIBE)) in people with Alzheimer's disease or a related disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Enrolled patients must have given themselves, or through a trusted person referred to the Article L. 1111-6 of the Code of Public Health, failing thereof, by the family, or, a person maintaining close and stable ties. For adults under guardianship, permission must be given by the legal representative of the person. The research will benefit from the backing of persons Protection Committee (PPC) prior to its implementation.
  • Patient living in one of the nursing home or hospital services in the project;
  • Patient with Alzheimer's or a related disease

排除标准

  • severe, progressive or unstable pathology, which may interfere with the evaluation variables;
  • deafness or blindness may compromise patient assessment

结局指标

主要结局

Correlation between SIWA and an other quality of life scale (Qol-AD)

时间窗: the Qol-AD is collected once. (Day 1)

In the Qol-Ad, the patient assesses the quality of life (bad / average / good / excellent) on five areas: relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality through 13 questions.

次要结局

  • Correlation between SIWA and an health scale (EQ-5D)(the EQ-5D is collected once. (Day 1))
  • Stability over time of SIWA(The SIWA is collected twice at ten minute intervals (Day 1))
  • Correlation between SIWA and behavioral and psychological symptom of dementia (BPSD) (NPI)(the NPI is collected once. (Day 1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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